Understanding Experiences of People With Spinal Cord Injury Undergoing Activity-based Rehabilitation

• ClinicalTrials.gov Identifier: NCT04000256
• Recruitment Status: Active, not recruiting
• First Posted: June 27, 2019
• Last Update Posted: April 7, 2023
• Sponsor: Thomas Jefferson University
• Collaborator: National Institute on Disability, Independent Living, and Rehabilitation Research
• Information provided by (Responsible Party): Thomas Jefferson University

Study Description

Brief Summary:

Incomplete cervical spinal cord injury (SCI) makes up half of all the newly admitted patients. For these individuals, the use of their upper limbs is critical for managing daily activities and self-care and impacts their quality of life. For home-based monitored rehabilitation, also called telerehabilitation, there are various rehabilitation equipment that are used. No studies have systematically gathered information regarding the perceptions of individuals with SCI regarding these equipment, training, and feasibility within the home. Further, their perceptions of the usability of high vs low end equipment is also not explored. In this study, investigators plan to gather survey and interview data from individuals with SCI regarding their experience with using rehabilitation equipment that uses games, muscle stimulation, and object manipulation. This study will inform the development of a tele-rehabilitation intervention in the future.

Condition or disease	Intervention/treatment
Spinal Cord Injuries	Behavioral: Activity based rehabilitation

Detailed Description:

Incomplete cervical spinal cord injury (SCI) makes up half of all the newly admitted patients. The overall prognosis for walking is better than the upper limb recovery in incomplete tetraplegia. Upper limb deficits result in difficulty in managing daily activities and self-care and impacts quality of life. Rehabilitation of the upper limb involves high intensity repetitive activities that are directed to a specific task. The demands of these programs can be up to 5 hours of therapy, 5 days a week for 12 weeks. Home-based therapies augmented by tele-rehabilitation presents a more realistic alternative to clinic-based application of these programs due to transportation and time commitment. However, engaging and motivating therapy options are needed for home to enhance client outcomes and improve compliance. Some of the latest equipment provides this capability and engages the patient using games for training. However, high equipment cost limits its widespread use.

In this study, we will engage individuals with cervical SCI in a 4-week (8 visit) evaluation of a variety of training protocols to gather information on their perceptions regarding motivation, engagement, and challenge it offers; its ability to address limitations they experience; and its feasibility within the home.

The long-term goal of this National Institute of Disability Independent Living and Rehabilitation (NIDILRR) funded Spinal Cord Injury Model System (SCIMS) project is to develop an engaging and evidence-informed intervention for home-based upper limb activity-based rehabilitation in individuals with spinal cord injury (SCI). A review of literature was recently conducted by the research team to get a scope of the evidence related to current activity-based therapies and the equipment used to deliver these programs. There is insufficient information about the value of high-end equipment involving games relative to lower cost alternatives, or the perceptions of clients regarding the use of various technologies related to motivation, engagement, appropriate level of difficulty and feasibility within the home. This lab-based study aims to understand the experiences related to rehabilitation training and high and low end equipment for upper limb activity-based rehabilitation in individuals with spinal cord injury.

Study Design

• Study Type: Observational
• Estimated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Understanding Experiences of People With Spinal Cord Injury Undergoing Activity-based Rehabilitation
• Actual Study Start Date: June 1, 2019
• Estimated Primary Completion Date: June 15, 2024
• Estimated Study Completion Date: June 15, 2024

Groups and Cohorts

Group/Cohort	Intervention/treatment
Spinal Cord Injury; The data during the first visit involves questionnaires, performance and observational measures for baseline evaluation. The 2nd to 8th visit involves feedback survey and interview data collection based on experiences of participants undergoing activity-based training using upper extremity rehabilitation equipment.	Behavioral: Activity based rehabilitation; Activity based rehabilitation for the upper extremity involves various gross and fine movements, reach and object transportation, and object manipulation. The rehabilitation equipment used during training will include gaming and instrumented training equipment, conventional table-top tasks, and exercise aids.

Outcome Measures

Primary Outcome Measures :

1. 10-item questionnaire [ Time Frame: Week 4 ]
   Quantitative feedback using a 10-question survey regarding experiences with the rehabilitation training and equipment for feasibility, motivation, engagement and difficulty.

Secondary Outcome Measures :

1. Qualitative interview [ Time Frame: Week 4 ]
   Interview to explore further the experiences with rehabilitation training and equipment.
2. Qualitative interview [ Time Frame: Week 2 ]
   Interview to explore further the experiences with rehabilitation training and equipment.
3. 10-item questionnaire [ Time Frame: Week 2 ]
   Quantitative feedback using a 10-question survey regarding experiences with the rehabilitation training and equipment for feasibility, motivation, engagement and difficulty.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Adults 18 years or older with chronic stable cervical spinal cord injury affecting one or both arms

Criteria

Inclusion Criteria:

1. Motor incomplete cervical SCI, neurologic levels C1-C7
2. Atleast one arm with active shoulder flexion (reach with gravity eliminated) and atleast one grasp pattern/able to move fingers
3. At least 6 months post injury
4. At least one arm with greater than 50% normal passive range of motion in all upper limb joints, excluding the interphalangeal joints of the fingers
5. Medically stable with no contraindications to the activities or to sitting
6. 18 years of age or older

Exclusion Criteria:

1. Uncontrolled pain in the upper limbs
2. Upper extremity amputations
3. Unable to commit to at least 3 visits
4. Surgical procedures (e.g., tendon transfers) or orthopedic trauma (e.g., fracture) within the past 3 months
5. Other neurological conditions
6. Mechanical Ventilation

Contacts and Locations

Locations

United States, California

Chapman University

Orange, California, United States, 92866

United States, Pennsylvania

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

National Institute on Disability, Independent Living, and Rehabilitation Research

Investigators

• Principal Investigator: Ralph Marino, MD; Thomas Jefferson University

More Information

Publications:

Szturm T, Peters JF, Otto C, Kapadia N, Desai A. Task-specific rehabilitation of finger-hand function using interactive computer gaming. Arch Phys Med Rehabil. 2008 Nov;89(11):2213-7. doi: 10.1016/j.apmr.2008.04.021.

Gauthier LV, Kane C, Borstad A, Strahl N, Uswatte G, Taub E, Morris D, Hall A, Arakelian M, Mark V. Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of chronic upper extremity hemiparesis. BMC Neurol. 2017 Jun 8;17(1):109. doi: 10.1186/s12883-017-0888-0.

Thielen CC, Marino RJ, Duff S, Kaplan G, Mulcahey MJ. Activity-based Rehabilitation Interventions of the Neurologically Impaired Upper Extremity: Description of a Scoping Review Protocol. Top Spinal Cord Inj Rehabil. 2018 Summer;24(3):288-294. doi: 10.1310/sci2403-288.

• Responsible Party: Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT04000256
• Other Study ID Numbers: 19G.279
• First Posted: June 27, 2019
• Last Update Posted: April 7, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Participant data from both sites will be pooled for analysis and reporting of results
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: 1 year
• Access Criteria: De-identified data only

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Jefferson University:

Spinal cord injuries; Telerehabilitation; Qualitative

Additional relevant MeSH terms:

Spinal Cord Injuries; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System